Would you like to be a key part of the Global Auditing at Novartis, building upon and maintaining our exceptional standards? We are looking for outstanding professionals with experience as GCP/PV Auditor with a passion for quality and a patient focus. As GCP/PV Senior Auditor at Novartis, you will manage cost-effective GxP Compliance and/or Audit activities, operations, and systems to ensure compliance of business areas with the Novartis Quality Manual and Policies and all relevant GxP, legal, and regulatory requirements, through internal audits, KPIs (Key Performance Indicators), and KQIs (Key Quality Indicators).
Your responsibilities include, but are not limited to:
Lead, plan, conduct, document, and follow-up on global quality regulatory compliance audits and assessments of GCP/GPvP according to the requirements specified in the respective Novartis Quality Module as well as applicable regulations, standards, quality agreements, and guidance documents.Perform activities with a high degree of independence.Prepare audit reports according to NVS requirements and timelines.Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures according to NVS requirements on Management Escalations and other relevant procedures.Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with Follow-up Responsible Person (FURP) and Quality Responsible Person (QARP).Mentor junior GCP/PV staff as required. Commitment to Diversity & Inclusion: We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Minimum Requirements: What you'll bring to the role:
10 years of GCP/PV/Pharmaceutical Industry/Health Authority experience or equivalent.At least 3 years of GCP/PV auditing experience; experience in both PV and GCP auditing is ideal.Ability to independently manage and objectively evaluate complex compliance issues with minimal supervision.Flexibility and willingness to travel up to 60%.Experience dealing with Health Authority inspections is a plus.Strong knowledge of GCP, GVP, GxP regulations.Fluency in English is essential - written and spoken. Additional languages are welcome. You will receive: Competitive salary, annual bonus, company pension plan, health insurance, life and accidental insurance, flexible working arrangements, subsidized dining facilities, employee recognition scheme.
Why consider Novartis? 766 million lives were touched by Novartis medicines in 2021, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives. We believe new insights, perspectives, and ground-breaking solutions can be found at the intersection of medical science and digital innovation.
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